HAWK Advanced Hypothermia Management Set, Item Number: 59-320
This recall is currently active, issued September 19, 2024. It was issued by Safeguard Us Operating Llc.
- Company
- Safeguard Us Operating Llc
- Recall Initiated
- August 27, 2024
- Posted
- September 19, 2024
- Recall Number
- Z-3182-2024
- Quantity
- 408 units
- Firm Location
- Harrisburg, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect expiration date.
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.
Lot / Code Info
Item Number: 59-320; Lot Numbers: PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580.
Root Cause
Process control
Action Taken
Safeguard US Operating notified customers via letters sent on 08/27/2024. Customers were instructed to remove the Convenience Kits from all points of use and return to Safeguard US Operating LLC for label correction of the HAWK component. Also complete the attached Recall Acknowledgement and Receipt Form and return it to Safeguard US Operating LLC per the instructions on the form. Distributors were instructed to carry out the recall to the consumer/user level and to identify customers who received the product and notify them of the recall, including a copy of the letter to enhance notification.